Umbilical probe system

ABSTRACT

An umbilical probe sensing system is described which includes an automated system for accurately obtaining physiological information from an infant in real time. The system may also automatically guide a healthcare provider with a recommended course of treatment for infant resuscitation based on the detected and monitored physiological data. Moreover, the automated system may also provide a real time record of the infant&#39;s physiological parameters and resuscitation treatment performed by a healthcare team.

CROSS-REFERENCE TO RELATED APPLICATION

The present application is a divisional of U.S. patent application Ser.No. 13/044,943 (Attorney Docket No. 34909-703.202, now U.S. Pat. No.______), filed Mar. 10, 2011; the full disclosure of which isincorporated herein by reference.

BACKGROUND OF THE INVENTION 1. Field of Invention

The present invention relates to methods and apparatus for sensing oneor more physiological parameters from a newly born infant. Moreparticularly, the present invention relates to methods and apparatus forsensing one or more physiological parameters from a newly born infantand guiding a treatment for the infant utilizing the sensedphysiological parameters.

With 4.2 million babies born yearly in the United States alone, 10% ofall these newborns require some assistance to initiate breathing atbirth and 1% of all these newborns require extensive resuscitation tosurvive. To assist medical care providers in the resuscitation of theseinfants, the American Academy of Pediatrics (AAP) and the American HeartAssociation (AHA) have developed a standardized sequential system,commonly known as the Neonatal Resuscitation Program (NRP) forevaluating a newborn and administering resuscitative measures which mayinclude the application of pressurized oxygen, chest compressions,medications and endotracheal intubation to prevent asphyxiation, braininjury and death following birth.

In order to participate in neonatal resuscitation, a practitioner istypically enrolled in a certified NRP class which requires thememorization of clinical algorithms, passage of a written exam, anddemonstration of clinical proficiency in neonatal resuscitationprocedures. They are then granted a 2 year certificate attesting totheir competency in performing neonatal resuscitation. NRP competencyhas become the standard of care for granting privileges to physicians tocare for infants in hospital nurseries throughout the U.S.

Neonatal resuscitation is a complex system of procedures, decisionmaking and medication administration based on a memorized algorithm withtime constraints performed under pressure while a newborn is dying. Theinfant's life depends on the practitioner memorizing this algorithm,guessing the weight of an infant, counting the infant's heart rate andincorporating the appropriate procedures, medication administration andcalculating appropriate device sizes and medication dosages based onapproximation of the infant's weight. Presently, there are no assistivedevices to measure the infant's weight, measure heart rate, calculateappropriate device sizes, calculate appropriate medication dosages, paceprocedures, time procedures and medication administration andsimultaneously record and create a document that represents theresuscitative effort for the medical record. In addition, the currentmedical culture does not provide a system to gather and analyze outcomedata from present resuscitation methods for refinement.

After a baby is born (either vaginally or by cesarean section), theumbilical cord is clamped with a plastic clip and cut by a physician andhanded off to another physician or nurse to be laid on a neonatal warmerfor evaluation. The clamp is permanent and non-adjustable and typicallycrushes the tissue of the umbilical cord and is placed randomly alongthe cord. A theoretical clock starts upon arrival of the baby to thewarmer. Within the first 30 seconds, the baby is dried, stimulated,positioned and airways are cleared of secretions with a suction device.The baby is typically evaluated for resuscitation based on threevariables: breathing efficiency, heart rate, and color. However, thetime to the first data acquisition of a distressed infant can rangeanywhere from thirty seconds to a few minutes. Moreover, the methodologyfor obtaining the physiological information from the infant typicallyinvolves obtaining the heart rate by squeezing the umbilical cordbetween the thumb and index finger and counting pulsations, using astethoscope to listen to the lungs and an estimate or guess of neonatalweight. Such measurements are open to human error and subjectivity. Ifthe baby is actively breathing, heart rate is greater than 100 beats perminute (BPM) and central color is pink, the baby is observed and givenan evaluative score called the Apgar score at an interval of 1 minute, 5minutes, and 10 minutes. The infant is then returned to the mother.

On the other hand, if the baby has either poor or no respiratory effort,a heart rate less than 100 BPM or central cyanosis, a time basedalgorithm is enacted. Each 30 seconds the infant is re-evaluatedutilizing these three criteria and a new set of procedures are performedand/or medications are administered. The baby's weight is estimated andappropriate sized devices and medication dosages are mentally calculatedbased on this weight estimate. Also, the physiologic data is obtainedonly intermittently with about thirty seconds between data points andthe determination of the data is also time-consuming.

Currently the health care provider sets up the neonatal warmerequipment, resuscitation equipment, equipment settings and medicationsby memory usually without an assistive device. They then simultaneouslyevaluate the baby's respiratory effort, color, heart rate, and estimateweight and time elapsed without assistive devices.

Neonatal heart rate is typically obtained by a health care practitionerafter birth by squeezing the thumb and index against the umbilical cordand counting the number of pulsations over a 6 to 30 second period.Heart rate evaluation is subjective and biased by psychological pressureplaced on the practitioner to verbally state a heart rate to the teamunder time constraints in hopes to rapidly apply the NRP algorithm.Accuracy can be compromised by a desire for expediency. Heart rate datais manually intensive requiring one practitioner to stop all otherduties and procedures while assessing heart rate.

Presently, several types of physiological assessments for infants areeither not performed or are performed after several minutes of delay.For example, electrocardiogram (ECG) rhythm analysis is not performedbecause of the time it takes to place the leads on the infant and thepoor adherence properties of adhesives on wet, greasy skin. Similarly,pulse oximetry is not universally used by many institutions within thefirst few minutes of resuscitation. Moreover, standards for normaloximetry values within the first minutes of life are not yet universallyagreed upon and placement sites for pulse oximetry sensors have not yetbeen standardized. Additionally, pulse oximetry sensor signals aretypically not reliable within the first 75 seconds after placement andambient light also degrades oximeter signals. While the limbs and digitsof the infant are commonly used for sensor sites, infant movement of thelimbs and digits creates movement artifact leading to inaccuratemeasurements.

Neonatal temperature measurement is usually performed five to tenminutes after delivery. An adhesive-based probe is placed on the chestof the neonate, which has very poor adherence quality and poor signalreliability. Another measurement which is typically not routinelyperformed on neonates includes measurement of CO.sub.2 saturation.

Thus, the assessment and/or consideration of physiologic data isintermittent and not continuous. There are spot checks for physiologicdata collection during resuscitation that interferes with the timing andflow of procedures and medication administration. However, manualphysiologic data assessment creates unnecessary manpower, time andintellectual demands. The data is subjective and usually obtained undermoments of stress with poor reproducibility and high noise to signalratio. The type and quality of data that is acquired is variable frompractitioner to practitioner and institution to institution. Moreover,adding to the inaccuracy of the information are the forms of dataacquisition, e.g., the manual use of fingers to count pulsations in theumbilical cord or using variable qualities of stethoscopes bypractitioners of variable skill levels to listen for heart tones andrespiration rate.

Accordingly, medical records are presently subjective and most neonatalresuscitation records are retrospective and not recorded in real-time.When there is enough staffing to perform neonatal resuscitation, oneprovider is obligated as the event recorder. Tool size and medicaldevice placement is dependent on a guess of neonatal weight and age ofgestation. Procedure timing is also based on a best guess estimation ofsize of infant, intermittent spot physiologic data that is subjectiveand best estimate of time elapsed. Moreover, the time line is variableas many institutions use a viewable clock or timer. Also, the start timeof the timer is also variable and is typically interrupted by thedemands on practitioners to gather manually obtained physiologic data.

Medical dosages are mentally calculated during the resuscitation basedon best guess of weight and correlated with best guess of time elapsedfor timing of medication dosages. Oxygen blend settings are subject tothe preference of the practitioner present or the institution that theresuscitation is performed in, not on specific real time neonatalphysiologic data in congruence with standardized settings based onrandom control trial outcome data. Consequently, consistent dataacquisition is given secondary priority to performing procedures on theinfant.

With respect to the clamping of the umbilical cord or umbilical stump ofthe infant, the umbilical cord is typically clamped closed at anarbitrary location along the cord using a clothes pin-type clamp such asa Hollister Double-Grip Umbilical Cord Clamp™ (Hollister, PortMelbourne, Australia). The clamp provides hemostasis and the clampposition is fixed and permanent where the umbilical cord must be cut toremove the clamp. However, the clamp typically crushes the sight ofclamping such that the tissue is crushed and the blood vessels withinthe umbilical cord are rendered nonviable and inaccessible. A newsection of the cord must be severed to access intact umbilical vein andarteries. A second clamp is typically placed and locked on the umbilicalcord and scissors are used to cut between the two clamps severing theumbilical cord in half to separate the infant from the placenta.

Frequently, the permanent clamp is placed on the umbilical cord adjacentto the fetal skin on the umbilical stump thus crushing the remainingportion of viable umbilical cord. The pediatrician caring for the infantneeds a viable undamaged portion of the umbilical cord to gain access tothe umbilical vessels with a plastic catheter in order to draw blood,administer medications, and administer fluids. Frequently, an inadequateportion of umbilical cord is left for the pediatrician to gain venous orarterial access to the infant.

Additionally, if the healthcare provider requires intravenous access tothe infant, the umbilical cord stump is typically prepared by cuttingoff the permanent cord clamp and using two pairs of tweezers to thread along pliable catheter into the umbilical vein. The length of thecatheter insertion is usually estimated by the practitioner and theumbilical venous catheter is usually held in place by tying a ribbonaround the umbilical cord crimping the umbilical cord around theumbilical vein catheter. This procedure is usually performed three toten minutes into the resuscitation attempt and requires anywhere fromfive to fifteen minutes for correct placement of the catheter dependingon the skill level of the practitioner. However, the umbilical veincatheter is prone to being positioned incorrectly and dislodged if whenbumped.

Another difficulty in neonatal resuscitation is poor communicationamongst the resuscitation team. Practitioners can have stethoscopes intheir ears decreasing their ability to hear verbal communication byother practitioners. Physiologic data is announced verbally which can beeasily ignored or unheard by entire resuscitation team. Communicationcan also be inhibited by practitioner hierarchy. If the leader of theresuscitation team is making inappropriate decisions or assessments,higher skilled practitioners with lower job titles tend to notcommunicate in order to avoid interpersonal conflict.

Accordingly, there exists a need for methods and devices for accuratelyassessing the physiological conditions of a newly born infant in realtime and for facilitating the treatment of a distressed infant.Additionally, there also exists a need for methods and devices forclamping the umbilical cord while maintaining viable access to the cordand/or stump.

BRIEF SUMMARY OF THE INVENTION

An automated system may be utilized for accurately obtainingphysiological information from the infant in real time as well asautomatically guiding the healthcare provider with a recommended courseof treatment. Moreover, the automated system may also provide a realtime record of the infant's physiological parameters and resuscitationtreatment performed by the healthcare team.

Generally, an adjustable clamping sensor assembly may be placed by ahealthcare provider, e.g., obstetrician, nurse, etc., to a portion of anneonatal infant's umbilical stump and/or umbilical cord immediately orshortly after birth. The assembly may be temporarily secured against theabdominal wall of the infant while the assembly maintains umbilical cordvessel integrity. Placement can be corrected by loosening the clamp andadjusting the position along the cord.

The sensor assembly, platform upon which the infant may be placed, aswell any additional sensors may each be electrically coupled to acentral processor which may be further electrically coupled to a displayand/or user interface, e.g., monitor, interactive touchscreen, etc., aswell as an optional user interface, e.g., keypad, keyboard, mouse,microphone, etc., for interacting with the healthcare provider.

In use, once the sensor assembly has been adjustably affixed to theumbilical stump, the processor may begin to receive physiological datadetected from the infant. Alternatively, the processor may optionallybegin once the infant has been placed upon the platform. The sensorassembly may provide for a focal area of data collection and may alsoprovide a single site of data acquisition from the umbilical stump,which is a capillary rich site on the neonatal anatomy. Because thesensor assembly may be attached onto the umbilical stump by applyingcontrolled pressure below the level of tissue injury (e.g., a pound ormore of force), use of adhesives can be avoided as adhesives are proneto slip on wet or greasy neonatal skin and the signal quality andreliability are improved over sensors which are normally adhered to theinfant's skin.

Data acquisition may be nearly instantaneous once the assembly has beensecured along the umbilical cord stump and/or the umbilical cord. Forexample, physiological parameters such as heart rate, ECG waveform,oxygen saturation, weight, transcutaneous carbon dioxide level, etc.,may be detected by the assembly and relayed to the processor. Thecomputer displays the objective data on the interface for the entireteam to view.

Data may be gathered objectively by the probe thereby reducing the needfor multi-tasking or manually acquiring the information from the infant.Moreover, the assembly may also provide for a continuous stream ofphysiological information allowing for a more time sensitive evaluationof the neonatal physiologic state and which allows the practitioner tocontinue life-saving procedures while the system acquires thephysiologic data for the provider.

With the physiological data acquired automatically and in real time,this information may be obtained objectively rather than relying on thesubjective measurements prone to human error. Moreover, this informationmay be communicated directly to a processor which may evaluate the stateof the infant and automatically calculate and guide the practitionerwith an automated checklist for a recommended course of treatment basedupon accepted and standard methods for infant resuscitation.

Once an infant has been placed upon a platform electrically coupled tothe processor, an automated clock may be started by the processor andthe interface may provide visual and/or auditory prompts based on theprogrammed resuscitation algorithm to guide the practitioner. The systemmay thus provide objective time-elapsed pacing for decisions on timingof procedures and timing of medications to be administered. In oneexample, the system may keep the practitioner on an appropriatetime-line for endotracheal intubation and alert the practitioner whentwenty seconds has been exceeded or if there is a desaturation event orbradycardiac event during intubation.

Thus, the system may provide prompts and suggestions that trigger recallof the algorithm and may also optionally allow the practitioner toconfirm choices made by the provider or redirect the provider toappropriate decisions thereby decreasing decision errors. The system mayfurther prompt the provider when an appropriate procedure should beperformed and may optionally include a visual or auditory metronome toguide the technique of the provider, e.g., when providing certainprocedures such as positive pressure ventilations, chest compressions,etc. The system also can record population based actual timerequirements for procedures that are performed. Thus, the system maycollect the physiologic data for the practitioner, perform allcalculations based on an accurate objective weight, and may also providean objective physiologic status of the infant.

Additionally, the system may also provide for real time medical recordmaintenance by recording and storing the continuous physiologic datawith procedure timing and technique, medication timing and dosageoverlay coupled to an Apgar score, physiologic score along withresultant outcome data, etc.

Moreover, the system may further allow practitioners of varying skilllevel to place umbilical vein catheters immediately or shortly afterbirth for a resuscitation procedure.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a cross-sectional end view of an exemplary umbilical cordillustrating the blood vessels.

FIG. 2 shows an example, schematically, of one variation of the neonatalresuscitation system.

FIG. 3 shows a flow chart illustrating the guidelines for neonatalresuscitation and emergency cardiovascular care provided by the AmericanHeart Association which may be integrated into the neonatalresuscitation system.

FIG. 4 shows a flow chart illustrating one example of how the neonatalresuscitation system may be utilized.

FIG. 5 shows an example of a user interface for conveying physiologicalinformation in real time and for interfacing with the health careprovider.

FIGS. 6A to 6D show top, side, and perspective views of one example of aclamping assembly for obtaining physiological parameters from a newborn.

FIGS. 7A and 7B show side and top views of another variation of aclamping assembly.

FIGS. 8A and 8B show top views of another variation of the clampingassembly and how the assembly may accommodate a range of umbilical stumpsizes.

FIG. 9 shows a side view of another variation illustrating a clampingassembly which may be biased to tension the umbilical cord and stumprelative to one another to provide for a secure connection.

FIG. 10 shows a side view of another variation of a clamping assemblyutilizing a secure bridging member.

FIGS. 11A and 11B show side views of another variation of a clampingassembly having an adjustable bridging member.

FIG. 12 shows a side view of an umbilical vein catheter which may beinserted into the umbilical cord or stump.

FIG. 13 shows a side view of an umbilical vein catheter integrated witha clamping assembly.

DETAILED DESCRIPTION OF THE INVENTION

To facilitate the standardization of neonatal resuscitation amongsthealthcare providers and to potentially decrease infant mortality, anautomated system may be utilized for accurately obtaining physiologicalinformation from the infant (e.g., infant weight, heart rate, etc.) in areal time manner as well as automatically guiding the healthcareprovider with a recommended course of treatment (e.g., suitable devicesizes, medication dosages, etc.). Moreover, the automated system mayalso provide a real time record of the infant's physiological parametersand resuscitation treatment performed by the healthcare team.

Normally, the umbilical cord and/or umbilical stump UC contains twoumbilical arteries AR.sub.1, AR.sub.2 and one umbilical vein VN whichare embedded within a loose, proteoglycan rich matrix known as Wharton'sjelly WJ, as shown in the cross-sectional end view of FIG. 1. The clampassembly may be designed specifically for adjustable attachment toeither the umbilical cord or the umbilical stump depending upon thedesired application. With the neonate's umbilical cord UC typically cutand clamped after birth, physiological information of the infant isstill obtainable from the remainder of the umbilical cord and/orumbilical stump utilizing the clamp assembly described herein.

By utilizing this access to the umbilical cord and/or umbilical stump,the neonatal resuscitation system 10 may comprise a sensor assembly 18which is designed for adjustable attachment to the neonate's umbilicalcord and/or umbilical stump US. The sensor assembly 18 may be optionallydisposable after use. As shown in the schematic view of FIG. 2, thesensor assembly 18 may be attached directly to the umbilical stump US.In addition to the sensor assembly 18, the system 10 may also comprise aplatform 22 for supporting the newborn infant NI during resuscitationtreatment and which may include an optional self-warming area as well asan integrated scale. An additional sensor 20, e.g., temperature probe,may also be optionally provided for temporary attachment to the infantNI, if so desired.

Each of the sensor assembly 18, platform 22, as well as optional sensor20 may each be electrically coupled to a central processor 12 which maybe further electrically coupled to a display and/or user interface 14,e.g., monitor, interactive touchscreen, etc., as well as an optionaluser interface 16, e.g., keypad, keyboard, mouse, microphone, etc., forinteracting with the healthcare provider. The communication between thevarious sensors, displays and/or interface units, as well ascommunications with the healthcare provider may be accomplished by wiredcommunications methods. Alternatively, the communications therebetweenmay be accomplished by various wireless interface protocols as wellwhich are typically used, e.g., BLUETOOTH®, WiFi, radio frequency,microwave, cellular protocols, etc.

In use, once the sensor assembly 18 has been adjustably affixed to theumbilical stump US, the processor 12 may begin to receive physiologicaldata detected from the infant NI. Alternatively, the processor 12 mayoptionally begin once the infant NI has been placed upon the platform22. The sensor assembly 18 may provide for a focal area of datacollection that is subject to low motion artifact and may also provide asingle site of data acquisition from the umbilical stump US, which is acapillary rich site on the neonatal anatomy. Because of the number ofdifferent types of sensors which may be integrated compactly into theassembly 18, the number of wires that are in the resuscitation field maybe decreased. Moreover, because the sensor assembly 18 may be attachedonto the umbilical stump US by applying controlled pressure below thelevel of tissue injury, use of adhesives can be avoided as adhesives areprone to slip on wet or greasy neonatal skin and the signal quality andreliability are improved over sensors which are normally adhered to theinfant's skin. Furthermore, the sensor assembly 18 may also provide astandardized, controlled, reproducible level of tissue compression toprevent tissue necrosis at sensor sites. Tissue necrosis can occur withother types of probes that are tightened by the health care workersindiscriminately on limbs and digits.

The processor 12 may be programmed with any number of resuscitationtreatment algorithms which are designed to follow a particular treatmentalgorithm based upon the received physiological data as well as inputreceived from the healthcare provider. In one example shown in FIG. 3,an algorithm 30 as shown in a flow chart illustrates the guidelines forneonatal resuscitation and emergency cardiovascular care as provided bythe American Heart Association. Such an algorithm 30 may be programmedinto the processor 12 of the neonatal resuscitation system 10 toprovide, e.g., a resuscitation clock with timing, prompts for cuing thephysician to appropriate interventions, pacing interventions, dosing ofmedications, recording of the resuscitation event, and for sending thedata to a universal server, etc.

As seen, once the infant NI has been transitioned to the platform 22,the weight of the infant may be obtained automatically by the integratedscale and this weight may be transmitted to the processor 12, e.g., forautomatically calculating accurate dosages of various medications to beprovided to the infant NI. Platform 22 may be optionally preset totrigger various features, such as the timer, when a detected weightsurpasses a threshold value, e.g., 300 gram or more. The sensor assembly18 may be attached to the umbilical stump US either after placement uponthe platform 22 or after the point of delivery, e.g., by theobstetrician once the umbilical cord has been clamped. The sensorassembly 18, as described in further detail below, may incorporate oneor more sensors for detecting various physiological parameters in realtime such as piezoelectric sensors for detecting heart rate,electrocardiogram (ECG) sensors, infrared pulse oximetry sensors,capnometry probe, temperature, etc. In the event that one or moretemperature sensors are incorporated into the sensor assembly 18, theinfant's temperature may be detected and monitored nearlyinstantaneously and continuously. Moreover, the infant's temperatureinformation may be relayed to the processor 12 which may be furtherprogrammed to adjust the temperature of a warming element in theplatform 22 and/or control the heat lamps above the infant.

If the infant NI is breathing or crying and shows good tone 32, theinfant NI may be handed over to the mother for routine care 38. However,if the infant NI indicates respiratory distress, e.g., a detected heartrate below 100 BPM, gasping, or displays apnea 34, the system 10 mayautomatically detect the heart rate and oxygen saturation levels in realtime from the infant NI and automatically prompt the healthcare provideror team via the interface 14 (or through another prompt) to eithermonitor for labored breathing 36 and/or to take further steps such asclearing the airways, prompting for positive pressure ventilation (PPV),prompting for continuous positive airway pressure (CPAP) 42, etc.

The system 10 may also prompt the healthcare provider for input based ontheir observations and/or judgment for providing the automated treatmentoptions in response. Accordingly, the healthcare provider may inputinformation into the system 10 via the interface 14 and/or optionalinterface 16 such that the system 10 provides the appropriate treatmentoption 40, e.g., PPV, pulse oximeter oxygen saturation (SpO2)monitoring, etc. Each of the physiological parameters may be monitoredby the system 10 through the sensor assembly 18 (or other sensors incommunication with the processor 12) and in the event that the system 10detects a heart rate 44 falling below a specified parameter, e.g., 100BPM, the system 10 may automatically prompt the healthcare provider totake ventilation corrective steps. In the event the heart rate detectedby the system 10 falls below another specified parameter, e.g., 60 BPM,the processor 12 may be programmed to automatically prompt thehealthcare provider via interface 14 to consider intubation, chestcompressions, and/or coordination with PPV 48. If the detected heartrate remains below the specified heart rate parameter of, e.g., 60 BPM50, then the processor 12 may again prompt the healthcare providerthrough interface 14 to consider further interventions such as an IV ofepinephrine in which case the processor 12 may automatically calculatethe correct dosage based upon the measured weight of the infant NI andprovide the dosage to the healthcare provider. Alternatively, thehealthcare provider may be prompted through interface 14 in the eventthat the detected heart rate rises above the specified parameter toconsider ventilation corrective steps, such as intubation or otherinterventions.

Although certain heart rate parameters are specified herein and in thefigures, they are provided merely as illustrative examples which may beprogrammed into the system 10. Any particular heart rate parameter mayaccordingly be specified and set by, e.g., the practitioner,manufacturer, AAP, AHA, etc. and the system 10 is not limited to beingprogrammed to any particular heart rate parameter.

In the algorithm of FIG. 3, rather than having the healthcare providerrely on memory alone, the system 10 may automatically prompt and guidethe provider with the appropriate measures while following thealgorithm. Based on the physiological parameters, as measured by thesensor assembly 18 as well as platform 22 and any other sensors 20, theprocessor 12 may monitor and record this data in real time to provideaccurate information independent of subjective measures prone to humanerror as well as to provide guidance in prompting the provider to followthe recommended resuscitation algorithm.

FIG. 4 illustrates another example in the flowchart 60 which shows howthe physiological parameters 62 detected via the system 10, such asthrough the umbilical probe sensor assembly 18, may be integrated withthe algorithm of FIG. 3. As illustrated, along with the real timeacquisition of the physiological information from the infant NI, thehealthcare provider or other member may optionally input additionalphysiological parameters 64 which may not have been measured by thesystem 10, e.g., through interface 14 or optional interface 16. Theprocessor 12 may take all the information and accordingly display theappropriate options based on the parameters 66 to the provider throughinterface 14. The provider may be automatically prompted to take aparticular intervention or course of action and/or the provider may befurther given the option to receive either the provided treatment optionor an alternative treatment option 68 in which case the provider mayindicate to the processor 12 through interface 14 and/or 16. Dependingupon the selected course of treatment by the provider, the processor 12may then calculate and display through interface 14 further treatmentoptions based upon the measured (or entered) physiological parametersand/or selected treatment options 70. The treatment and guidance throughthe algorithm may continue until the infant NI has been successfullyresuscitated or until the system 10 has been stopped by the provider oroptionally timed out automatically after a passage of time.

The interface 14, as previously mentioned; may function as a touchscreenfor receiving input from the healthcare provider. It may also functionas a monitor for displaying various data such as real time monitoredphysiological information as well as recommended treatment options. FIG.5 shows an example of a user interface 80 which may be displayed oninterface 14 showing, e.g., an interface for displaying infant vitalsigns 82 such as heart rate, oxygen saturation, weight, elapsed timefrom the start of treatment, etc., which may be displayed numerically orgraphically depending upon the desired interface. Interface 14 may alsodisplay an interface 84 for prompts and/or alerts which mayautomatically display to provide guidance and recommendations to theprovider for infant treatment. The recommended treatment may, of course,depend upon the physiological data of the infant NI detected by thesystem 10 as well as the course of treatment provided by the providerand optionally input into the system 10. Additionally, the userinterface 80 may also comprise a measurements interface 86 which maydisplay information such as calculated values for drug injections (e.g.,epinephrine, etc.) or device sizes (e.g., tubes, etc.) which may becalculated automatically by the processor 12 and displayed on interface86 depending upon the measured physiological data of the infant asmeasured by the system 10 or optionally input by the provider. Moreover,user interface 80 may also optionally include a documentation and/ortimer interface 88 which may provide an interface for automaticallyrecording not only the real time physiological data of the infant butalso any medication and dosages provided as well as the parameters ofany other interventional procedures which may have been performed uponthe infant.

Although the documentation and/or timer interface 88 may be displayed ona touch screen, they may alternatively include physical buttons as well.Moreover, the interface 88 shown is illustrative of the various featuresavailable and may include any number of features, e.g., Start, Stop,Active Respirations, Blow-by, APGAR, PPV, CPAP, Compressions,Intubation, Narcan, Epinephrine, Surfactant, Fluid Bolus, Bicarbonate,UVC, UAC, OG Tube, Peripheral IV, CBG, etc.

To facilitate the interaction with the provider, any touch screenbuttons on interface 80 may light when touched and may remain lighted asan indicator that a particular procedure is being performed. Forexample, the pressing of the “Weigh” button on timer interface 88 mayinitiate the algorithm and resuscitation timer. Depressing the “PPV”button may trigger a pacing tone at, e.g., 30 beats/second, to guide theprovider while the pacing tone may be canceled by depressing the “PPV”button a second time. Depressing the “Compressions” button may alsostart a pacing tone to guide the provider for chest compressions at,e.g., 90 beats/second, and an illustration of the appropriate positionon the infant's chest for compressions may be displayed on the userinterface 80 for a period of time, e.g., 5 seconds, as a reminder to theprovider.

When prompting or alerting the provider with an alarm or recommendedcourse of treatment, the user interface 80 may incorporate any number ofdisplays. For example, the detected physiological data or prompts may becolored (e.g., red, green, etc. depending upon the status) and/or sizeddifferently from other text on the interface 80.

The user interface 80 is represented as an example of one variation ofsuch an interface which may be displayed upon interface 14. Each of theparticular interface features may be modified or omitted entirelydepending upon the desired features. However, the user interface 80 isprovided as an example of how the various physiological parameters maybe detected by the system 10 and displayed to the provider as well asexamples of how the interface 14 may also provide guidance and promptingto the provider for accurately guiding the provider through aresuscitation algorithm which is correlated to real time monitoredphysiological information from the infant.

Because the physiological information and provided procedures may berecorded automatically, the information may be stored in the system 10for later analysis and/or it may be optionally transmitted to a separateserver, such as by encrypted data storage and/or encrypted datatransfer, which may accept and store the information. The captured datamay be stored for analysis by the healthcare providers at a later timeor for access by other parties, e.g., an expert panel of neonatologists.Additionally, the recorded information may also be used for performancefeedback to institutions and individual practitioners or optionally forfuture research for improving neonatal resuscitation.

Another example of how the resuscitation system 10 may be utilized isfor use as a training implement for neonatal resuscitation. Theprocessor may be configured to provide a training modality that mayoptionally utilize a computerized training infant analog which may beinterface with the system in real time as a real life infant. Therecorded treatment procedures may be optionally used for trainingneonatal resuscitation and may be used to evaluate and scorepractitioner competency.

Another example may include the processor in the system 10 beingprogrammed to create and/or send via a wired or wireless protocol (e.g.,text messaging, email, cellular protocols, etc.) information to selectedindividuals. For instance, the system 10 may create a birth announcementwith selected information which may be predetermined and/or selected bythe birth mother, certain family members, or practitioner where theselected information may include information such as the infant'sweight, etc. Such an announcement may be created automatically by thesystem 10 and/or after the birth by the system 10 and sent via the wiredor wireless protocol to the selected individuals either automatically orupon final approval by the birth mother or family member or otherapproved individual.

Turning now to the sensor assembly, one variation of a clamp assembly 90which may be temporarily attached to the umbilical cord or umbilicalstump US of the infant for sensing and monitoring physiologicalparameters is shown in the top, side, and perspective views of FIGS. 6Ato 6D. Generally, the sensor clamp assembly functions to gather neonatalphysiologic data within the first few seconds after birth, as previouslymentioned. It also maintains continuous physiologic data capture for atleast the first few hours of life and further gathers neonatalphysiologic data using multiple sensory modalities without the need foradhesives to adhere to the neonatal skin contact areas.

As described above, the base portion of the sensor clamp assembly mayabut the neonatal abdomen and extend a length above the abdomen forattachment to a length of viable umbilical cord prior to cutting of thecord by the delivering physician. Due to the size of the assembly, itmay also provide for a standardized length of the umbilical cord to becut such that a standard predictable length (e.g., for use withumbilical vein or arterial catheters) is provided for futureintravascular access by the provider. The clamp site on the umbilicalcord is not crushed by the clamping apparatus due to the relatively lowpressure applied by the assembly yet the assembly may provide enoughclamping force which provides for hemostasis yet maintain blood vesselviability and integrity for future access for cannulation by thepediatrician. The adjustable clamp tension may also allow thepractitioner to adjust the position of the clamp on the umbilical cordor stump US. Because the assembly may provide for a standardizedprotected length of viable umbilical stump US, the assembly may providefor a one-size-fits-all length of catheter. Moreover, because the clampassembly is adjustable, it may hold the sensors integrated along theassembly in a fixed position relative to the umbilical cord or stumpwithout the need for adhesives.

In the particular variation shown, the clamp assembly 90 may generallycomprise a pair of stabilizing members 92 which form a contact surface106 for optional placement against the skin surface of the infant NIsurrounding the umbilical stump US. The stabilizing members 92 are shownas curved or arcuate members which extend into apposition relative toone another to form an opening 94 for receiving the umbilical stump USand/or umbilical cord, e.g., forming a diameter of 0.5 to 4 cm, althoughthe diameter may be formed to be lower or greater depending upon thedesired size. A pair of first stabilizing arms 96 may protrude into theopening 94 from between the stabilizing members 92 and form a receivingchannel 98 such that each of the first stabilizing arms 96 areadjustable relative to one another and biased towards one another totemporarily clamp over or onto a portion of the umbilical stump US. Thefirst stabilizing arms 96 may be positioned relatively closer towardsthe contact surface 106.

A second pair of stabilizing arms 100 may be positioned in proximity tothe first stabilizing arms 96 such that a receiving channel 102 definedby the second stabilizing arms 100 is aligned collinearly with thereceiving channel 98 formed by the first stabilizing arms 96. Moreover,the second stabilizing arms 100 may be positioned upon an adjustableneck 104 which allows for the relative adjustment between the first andsecond stabilizing arms 96, 100. In use, while the first stabilizingarms 96 may hold onto the umbilical stump US to maintain its position,the second stabilizing arms 100 may also clamp temporarily onto an upperportion of the umbilical stump US or upon a portion of the umbilicalcord such that the umbilical stump US is maintained in a secureconfiguration relative to the infant's body.

In yet another alternative, the second stabilizing arms 100 may beseparated from the first stabilizing arms 96 and removed from theassembly leaving the first stabilizing arms 96 clamped upon theumbilical stump US to provide hemostasis.

As described in further detail below, a number of different types ofsensors may be integrated into the clamp assembly 90, e.g., within thefirst or second stabilizing arms 96, 100, along the stabilizing members92 (such as a sensor “puck” insertable into the base), or in otherlocations along the clamp assembly 90 in proximity or in contact withthe umbilical stump US. In one example, one or more sensors along theclamp assembly 90 may comprise piezoelectric sensors in contact with theumbilical stump US for detecting the infant heart rate. Additionally,one or more electrocardiogram (ECG) sensors may also be integrated aswell as one or more infrared sensors for pulse oximetry.

Attaching the clamp assembly 90 to the umbilical stump US and detectingan infant's heart rate can potentially be performed, e.g., in less than10 seconds, whereas detection of an infant's pulse would usuallyotherwise take more than 60 to 70 seconds. Moreover, because theinfant's heart rate is measured directly from the blood vesselsremaining within umbilical stump US (and/or skin and abdominal wall),the measurement is objective and not limited to subjective manual heartrate detection by a medical practitioner. Additionally, because theclamp assembly 90 may remain secured to the umbilical stump US for theduration of the resuscitation (or even afterwards), the sensor mayprovide a continuous data stream of neonatal heart rate throughoutresuscitation and/or during neonatal I.C.U. or neonatal nursery stay.

Additionally, the ECG sensors (e.g., silver-silver chloride conductancepads or any other conductance type pads) integrated into the clampassembly 90 may also detect and monitor the infant's ECG waveformsthroughout the resuscitation procedure to also provide the ability forreal time monitoring and analysis of cardiac waveform and rhythmanalysis as well as providing the opportunity for earlier heart rate andrhythm analysis for interventions not previously included inconventional neonatal resuscitation algorithms. The assembly 90 may alsooptionally provide sensors for transthoracic impedance plethysmographysensing for neonatal blood flow analysis. The assembly 90 may furtherprovide, e.g., transcutaneous capillary pH analysis, transcutaneouscapnometry analysis, transcutaneous capillary blood glucose levels,non-contact pulse oximetry, CMOS-based digital imaging, radio-frequencysensors, piezoelectric sensors, etc.

The assembly 90 may also hold the umbilical cord or stump US relativelyupright relative to the infant abdomen and taut between the first orsecond stabilizing arms 96, 100 to facilitate intravascular access andmay be secured to the infant utilizing a single hand of the provider.

Another variation of the sensor assembly is shown in the side and topviews of FIGS. 7A and 7B, which illustrate a clamp assembly 110 securedto a portion of an umbilical stump US. In this variation, the assembly110 may generally comprise a first securement member 112 which may besecured to a second securement member 132 positioned in appositionaround, across, or adjacent to the umbilical cord UC or stump US. Wires122 attached to one or both of the members 112, 132 may electricallycouple the assembly 110 to the processor 12. The assembly 110 mayincorporate any of the various sensors described herein although theexample illustrated shows a first ECG lead 114 positioned along firstsecurement member 112 and a second ECG lead 126 positioned along secondsecurement member 132 such that when the members 112, 132 are secured tothe umbilical stump US the ECG leads 114, 126 are aligned in appositionto one another across the umbilical stump US thus allowing for the leads114, 126 to detect the signals across the stump US. Also illustrated isa light emitting diode (LED) 116 positioned along second member 132 andphotodiode 124 positioned along first member 112 in apposition relativeto one another such that the emitted light from LED 116 may betransmitted into a portion of the skin along the umbilical stump US anddetected by the corresponding photodiode 124. In the event that lightreflectance is used to detect the signals rather than light transmissionentirely through the stump US, the securement members 112, 132 may besecured across or adjacent to the stump US such that the light sourcemay be positioned adjacent to the photodetector to receive reflectedlight from the stump US rather than transmitted light.

Although described with the use of wired communications, the detectedand sensed information may alternatively be transmitted using variouswireless communications protocols such as those described above, e.g.,BLUETOOTH®, WiFi, radio frequency, microwave, cellular protocols, etc.

To facilitate placement and alignment of the members 112, 132 relativeto the umbilical stump US, one or more optional external indicators ormarkers 118 may be positioned along the members 112, 132 to aid withaligning the integrated sensors with the umbilical stump US.Additionally, one or both members 112, 132 may also optionally includetemperature sensor 120 along a portion of the assembly 110 whichcontacts the abdominal skin surface of the infant.

Because the size of the umbilical cord UC and/or umbilical stump US mayvary between infants, the assembly 110 may have its first securementmember 112 made from a flexible layer 138 and second securement member132 also made from a flexible layer 134 which may each have a respectiveadhering layer 140 and 136, as shown in the top view of FIG. 8A, whichis positioned to be in apposition relative to one another. Each of theadhering layers 136, 140 may be made from a gelatinous adhesive that mayadhere at least temporarily not only to one another but also around theumbilical stump US. With the flexibility of the members 112, 132, theassembly 110 may define a conforming region 130 which can vary in sizeto accommodate variably-sized umbilical stumps 142, as shown in FIG. 8B,while the members 112, 132 adhere to one another along contact regions128 on either or both sides of the umbilical stump US with a relativelylow compressive force exerted onto the umbilical stump US. In thismanner, each of the sensors may remain in contact against the surface ofthe umbilical stump US for sensing. Moreover, the assembly 110 may berepositioned and/or removed from the umbilical stump US onceresuscitation has been completed or until a later time.

FIG. 9 shows a side view of another variation in which a clamp assembly150 may generally comprise a clamping structure having, e.g., a biasingmechanism to maintain probe position and contact against the skin of theinfant IN. As shown, the clamping assembly 150 may have a first supportmember 152 extending to a first clamping member 154 which defines afirst receiving channel 164 for temporarily clamping onto a portion ofthe umbilical stump US. First support member 152 and first clampingmember 154 may be optionally angled relative to one another tofacilitate positioning of the first clamping member 154 against theumbilical stump US. Similarly, second support member 156 may extend atan angle relative to first support member 152 with second clampingmember 158 extending optionally at an angle relative to the secondsupport member 156. A second receiving channel 166 may be defined at adistal end of the second clamping member 158 for securement onto adistal portion of the umbilical stump US or along a portion of theumbilical cord UC, as shown. One or more wires 162 may electricallycouple the integrated sensors positioned within one or both of thereceiving channels 164, 166 of the assembly 150 to the processor 12.

The first and second support members 152, 156 may be pivotably coupledto one another in a biased connection 160, e.g., in an articulatedspring-loaded coupling, which may urge the members 152, 156 away fromone another, as indicated by the arrow. With the first clamping member154 secured to the umbilical stump US and against the abdominal skin ofthe infant IN and with second clamping member 158 secured to an upperportion of either the umbilical stump US or umbilical cord UC, e.g.,about 3 cm away from first clamping member 154, the assembly 150 may besecurely held in position relative to the infant IN to maintain thesensors in contact with the infant IN, umbilical stump US, and/orumbilical cord UC. Additionally, because of the biasing force from theconnection 160, the umbilical stump US and/or umbilical cord UC may bemaintained in a straightened configuration relative to the abdomen ofthe infant IN allow for intravascular access.

Yet another variation is shown in the side view of FIG. 10 whichillustrates clamp assembly 170 which may be comprised generally of afirst support member 172 which defines a first receiving channel 178 forreceiving the umbilical stump US and a second support member 174 whichdefines a second receiving channel 180 for receiving an upper portion ofthe umbilical stump US or umbilical cord UC. The support members 172,174 may be attached to one another via a bridging member 176 which mayadjust a height between the members 172, 174. Optionally, the secondsupport member 174 may be separated from the first support member 172and removed from the assembly leaving the support member 172 clampedupon the umbilical stump US to provide hemostasis. The remaining portionof the clamped umbilical cord UC may be left flaccid to lie against theabdominal wall after the need for resuscitation has passed.

The assembly 170 as well as each of the other variations shown anddescribed herein may incorporate any number of the sensors within theassemblies for detecting and monitoring the physiological parameters ofthe infant from the umbilical cord UC and/or umbilical stump US.Moreover, each of the assemblies may be adjustable to vary the heightbetween the securement members as desired or necessary. Furthermore, thesurface of the clamping members in any of the variations herein may beoptionally roughened or they may integrate projections or protrusions toinhibit slippage between the umbilical tissue and the assembly.

Yet another variation is shown in the side view of FIGS. 11A and 11B,which illustrate a clamp assembly 190 having a base 192 which defines anopening for receiving the umbilical stump US. The bridging member 194may extend from the base 192 and have an adjustable clamp members 196extending from the base such that the opening of the clamp members 196is aligned with the opening through the base 192 for holding theumbilical cord UC and/or umbilical stump US. The clamp members 196 maybe adjustably positioned along the bridging member 194 to vary itsheight relative to base 192, as desired. The one or more sensors may behoused within the base 192 for contact with the umbilical stump US.

With the clamping assembly maintaining a secure configuration of theumbilical stump US or cord UC, the assembly presents an entry point foran umbilical vein catheter (UVC) 200 which may be utilized with theclamping assembly for gaining intravascular access to the infantsvascular system via the umbilical stump US or cord UC. As shown in theside view of FIG. 12, an example of a UVC 200 is illustrated as having acatheter length 202 with a tapered tip 204 and an adjustable dial 206.

In use, the UVC 200 may be inserted into the umbilical cord UC or stumpUS with a proximal portion of the catheter 200 secured to the clampmembers 196, as shown in the side view of FIG. 13. The adjustable dial206 may be further secured to the assembly 190 via a lock 208 which mayattach the dial 206 to a portion of bridging member 194. Once the UVC200 has been inserted into the umbilical stump US and locked to assembly190, dial 206 may be rotated to adjust a depth of the tip 204 relativeto the assembly 190 and umbilical stump US. For example, dial 206 may berotated until the tip 204 is at a depth of, e.g., about 2 cm, below theabdominal wall in the umbilical vein.

Umbilical vessel catheterization usually is usually performed 5 to 10minutes into a resuscitation attempt and typically requires 5 to 15minutes of practitioner time to properly place and secure in positionthe UVC. However, utilizing the clamping assembly, the UVC 200 may beplaced within the umbilical vessel within, e.g., the first 30 seconds ofa resuscitation and may require less than one minute of practitionertime. The use of UVC 200 may be integrated with any of the assembliesdescribed herein as desired or as practicable.

The applications of the devices and methods discussed above are notlimited to the securement of umbilical cords and stumps but may includeany number of further treatment applications. Moreover, such devices andmethods may be applied to other treatment sites within the body.Modification of the above-described assemblies and methods for carryingout the invention, combinations between different variations aspracticable, and variations of aspects of the invention that are obviousto those of skill in the art are intended to be within the scope of theclaims.

What is claimed is:
 1. A system for treating a neonatal infant,comprising: a processor programmed with a neonatal resuscitationalgorithm; a platform in communication with the processor for detectinga weight of the infant; a user interface in communication with theprocessor; and, an umbilical probe sensing assembly having one or moresecurement members attached to a base, wherein the securement membersare adjustably biased to attach temporarily onto an umbilical stump orumbilical cord such that the members inhibit necrosis of the umbilicalstump, and one or more sensors in communication with the processor andintegrated within the assembly such that the sensors are positioned tocontact the umbilical stump when the stump is secured to the assembly.2. The system of claim 1 further comprising a user input device incommunication with the processor.
 3. The system of claim 1 furthercomprising at least one additional sensor in communication with theprocessor.
 4. The system of claim 1 wherein the platform furthercomprises a warmer.
 5. The system of claim 1 wherein the user interfacecomprises a touch screen.
 6. The system of claim 1 wherein the one ormore securement members comprise a pair of arcuate members defining areceiving channel for receiving the umbilical stump therein.
 7. Thesystem of claim 1 wherein the one or more securement members are biasedto clamp temporarily onto the umbilical stump.
 8. The system of claim 1wherein the one or more securement members each comprise a layer havingflexibility sufficient to conform the layer around the umbilical stump.9. The system of claim 1 wherein the one or more sensors are integratedalong the one or more securement members.
 10. The system of claim 1further comprising a second pair of securement members attached along abridging member at an adjustable distance from the one or moresecurement members.
 11. The system of claim 1 wherein the one or moresensors comprise electrodes, infrared emitters, light emitting diodes,photodetectors, or temperature sensors.
 12. The system of claim 1further comprising an umbilical vein catheter which is securable to theassembly.